Prospective Huntington At Risk Observational Study

Huntington Disease Clinical Trial

— PHAROS  

Official title:

Prospective Huntington At Risk Observational Study (PHAROS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00052143
• Other study ID #: R01HG002449
• Status: Active, not recruiting
• Phase: N/A
• First received: January 23, 2003
• Last updated: April 15, 2009
• Start date: July 1999
• Est. completion date: July 2010

Study information

• Verified date: February 2008
• Source: Huntington Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to define the natural history and experiences of people who are at risk for developing Huntington's disease but who do not know their genetic status.

Description:

Huntington's disease (HD) is a genetic disease characterized by changes in movement and behavior. To date, little research has been done on individuals who are at risk for developing the disease. PHAROS is an observational study designed to monitor people who are at risk for developing HD, and to survey their attitudes and beliefs about their "at-risk" status. Investigators hope this study will help answer some important questions about HD, such as: 1.) What are the earliest signs of HD and when do they start? 2.) How accurate are the measures that physicians use in detecting the onset of HD? 3.) What factors influence the age at which a person carrying the HD gene develops the illness? and 4.) In a group of people at risk for HD, how many will develop signs of the illness over a minimum three-year period of observation?

Participants in the study will be evaluated every 9 months (for 5 years) using the Unified Huntington's Disease Rating Scale (UHDRS)--a clinical tool which looks at movement, psychological and behavioral function. The participants will also be asked to complete surveys about their mood, life events, and attitudes or beliefs about being at risk for HD. A blood sample, taken at the beginning of the study, will be confidentially tested to determine if the participant has the abnormal gene for HD. Neither the participant nor any of the PHAROS physicians or coordinators will learn the results of individual gene tests.

The scientists hope that this study will provide essential information for future trials of experimental drugs for HD.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1001
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 26 Years to 55 Years

Eligibility

Inclusion:

• Men and women between 26-55 years of age;

• Who are at risk for HD by virtue of having (or had) a parent or sibling with the illness;

• Who have never been tested for the HD gene, and who do not desire to be tested for the HD gene during the duration of the study;

• Agree to blinded (sample will be coded) genetic testing of the HD gene; and

• Who have never been diagnosed with HD.

Exclusion:

Individuals Who:

• have been diagnosed with HD;

• are taking antipsychotic medications;

• use antiemetic (anti-nausea) medications with on a regular basis (greater than 3 times per month); or

• exhibit clinical signs/symptoms of psychosis at the screening visit

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Huntington Disease

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	The Centre for Addiction and Mental Health	Markham	Ontario
Canada	Hotel-Dieu Hospital-CHUM	Montreal	Quebec
Canada	University of British Columbia	Vancouver	British Columbia
United States	Albany Medical College	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland at Baltimore	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Colorado Neurological Institute	Englewood	Colorado
United States	University of Connecticut	Hartford	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California at San Diego	LaJolla	California
United States	UCLA School of Medicine	Los Angeles	California
United States	North Shore-LIJ Health System	Manhasset	New York
United States	University of Miami School of Medicine	Miami	Florida
United States	Medical College of Wisconsin-Milwaukee	Milwaukee	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	NeuroHealth Parkinson's Disease Movement Disorders Center	Pawtucket	Rhode Island
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	University of California, Davis	Sacramento	California
United States	University of Washington and VA Puget Sound	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	UMDNJ Huntington Disease Service Center	Stratford	New Jersey
United States	University of South Florida	Tampa	Florida
United States	Hereditary Neurological Disease Center	Wichita	Kansas
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Huntington Study Group	National Human Genome Research Institute (NHGRI), National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Huntington Study Group PHAROS Investigators. At risk for Huntington disease: The PHAROS (Prospective Huntington At Risk Observational Study) cohort enrolled. Arch Neurol. 2006 Jul;63(7):991-6. — View Citation

External Links

•   study website